Consumer Group Petitions FDA to Pull Agency’s Approval of Seprafilm Anti-Adhesion Device

Consumer Group Public Citizen has petitioned the U.S. Food and Drug Administration (FDA) to withdraw approval of Sanofi SA’s Seprafilm and order a recall of the device, which has been associated with serious side effects including death.

Seprafilm, developed by Genzyme, is used to reduce abnormal internal scarring following surgery by separating tissues and organs as they heal. The FDA approved the anti-adhesion implant in 1996. An FDA spokesperson told Reuters it would directly respond to Public Citizen following the agency’s review of the petition.

At least nine reports of deaths associated with Seprafilm have been logged in the FDA database of Manufacturer and User Facility Device Experience over the last 10 years. In its 39-page petition, viewed by Reuters, Public Citizen said all three key studies used to prove Seprafilm’s efficacy contained protocol violations at a trial site and other serious flaws. Re-analysis of data from a postmarketing study was highly questionable, and the advocacy group said the device has drawn criticism from experts. The FDA had mandated a large postmarketing study to further assess the device’s safety.

In the petition, Public Citizen also questioned the design of two pivotal studies on which Seprafilm’s original marketing application was based on. Genzyme opted to evaluate incidence and severity of adhesions, rather than the device’s effectiveness at improving outcomes, the group said. The company theorized that such improvements would indicate meaningful clinical benefit, according to Reuters.

“Evidence of (Seprafilm’s) clinical efficacy has been sorely lacking despite widespread adoption,” Dr. Neil Hyman, a professor of surgery at the University of Chicago, wrote in 2006, Public Citizen said.

Public Citizen said it knew of at least 21 deaths linked to Seprafilm, and a limited search of an FDA database spanning January 1, 1998 through May 27, 2015, revealed 524 reports of related adverse events. The group said it is especially concerned that Seprafilm is increasingly being used for off-label purposes, Reuters reports.

Genzyme agreed in 2013 to pay the U.S. government $22.3 million to settle allegations that it encouraged inappropriate use of the device, according to Reuters.

“I don’t know what they’re (the FDA) going to do in this case… but it looks like it will take a couple of years before we know the answer”, Dr. Michael Carome, the director of Public Citizen’s Health Research Group, told Reuters.

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